Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
81337–81360 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2000
INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
K003450 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Dec 07, 2000
POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
K003452 · DRF
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Dec 06, 2000
DARDIK CAROTID SHUNT
K001621 · MJN
Vascutech, Inc.
Cardiovascular · 194d
Cleared Dec 06, 2000
STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
K001976 · DIS
OraSure Technologies, Inc.
Toxicology · 160d
Cleared Dec 06, 2000
SLEEPSTRIP DISPOSABLE APNEA SCREENER
K002135 · MNR
Influent , Ltd.
Anesthesiology · 145d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 135d
Cleared Dec 06, 2000
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K002794 · CBF
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · CBF
Hypertec, Inc.
Anesthesiology · 90d
Cleared Dec 06, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
K002798 · JEY
Codman & Shurtleff, Inc.
Dental · 90d
Cleared Dec 06, 2000
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K003455 · NFB
Chad Therapeutics, Inc.
Anesthesiology · 29d
Cleared Dec 06, 2000
EECP THERAPY SYSTEM, MODEL TS3
K003469 · DRN
Vasomedical, Inc.
Cardiovascular · 28d
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 27d
Cleared Dec 05, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001
K000582 · LFR
Abbott Diabetes Care, Inc.
Chemistry · 287d
Cleared Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND...
K001465 · FIB
Nipro Medical Corp.
Gastroenterology & Urology · 209d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · MLD
Siemens Medical Solutions USA, Inc.
Cardiovascular · 146d
Cleared Dec 05, 2000
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
K002128 · NDR
Diagnostic Systems Laboratories, Inc.
Chemistry · 144d
Cleared Dec 05, 2000
ACAPELLA
K002768 · BWF
Dhd Healthcare Corp.
Anesthesiology · 90d
Cleared Dec 05, 2000
DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM
K002775 · HRS
Hand Innovations, Inc.
Orthopedic · 90d
Cleared Dec 05, 2000
HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION
K002782 · LLZ
Nuclear Diagnostics AB
Radiology · 90d
Cleared Dec 05, 2000
FIXION INTERLOCKING NAIL (FIXION IL NAIL)
K002783 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Dec 05, 2000
MEDIPRIME
K002894 · LLZ
Algotec Systems, Ltd.
Radiology · 78d
Cleared Dec 05, 2000
JEWEL CAST III
K003037 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
GOLD CORE II
K003039 · EJH
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Dec 05, 2000
UBM PLUS, MODEL P45
K003141 · IYO
Paradigm Medical Industries, Inc.
Radiology · 56d